Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation

NCT01129999 | Completed DMC

• 2 other identifiers: DKH-Studie VT-HT108368
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive cognitive-behaviour interventions (CBT) combined with pharmacotherapy for smoking cessation are well established and have been proved to be efficacious. Nevertheless, they yield only long-term abstinence rates about 35%. Considering the high interest of smokers in alternative medicine, the availability of a broad range of treatment methods, of which smokers choose an intervention according to their preferences, might contribute to improve treatment outcome. While hypnotherapy (HT) is an already widely promoted alternative method for aiding cessation, considerable methodological shortcomings of studies on this topic limit the interpretability of the results. In 2006, the German Academic Advisory Committee for Psychotherapy released new guidelines that included HT as an acceptable treatment for smoking cessation. The committee conceded, however, that conclusions concerning its efficacy are restricted due to the heterogeneity of findings. Hence, further well-designed studies are required to better test the efficacy of HT in comparison to accepted treatments. This randomised, controlled trial aims to compare the efficacy of CBT and HT for smoking cessation. Further, the influence of moderating variables will be investigated. It is hypothesized that 1) participants receiving CBT will evince higher abstinence rates than those receiving HT, 2) levels of nicotine dependence, self-efficacy and motivation to change will moderate the intervention effects and 3) participants with high levels of suggestibility will evince higher abstinence rates in the HT-intervention compared to participants with low levels of suggestibility. 220 adult healthy smokers will be randomized to receive either CBT or HT. Both programmes will be conducted in 6, weekly, 90-minute group sessions. Participants will be followed up at 1, 3, 6, 9 und 12 month post-treatment. Generalized estimating equation models will be conducted to analyse group differences on abstinence rates. The models will include the above mentioned moderator variables.

Conditions

Smoking Cessation

Keywords

smoking cessation, CBT, hypnotherapy

Outcome Measures

Primary Outcomes (1)

• 12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)

  12-months follow-up

Secondary Outcomes (1)

• 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up

  12-months follow-up

Study Arms (2)

Cognitive-Behavioral Therapy

EXPERIMENTAL

Behavioral: Cognitive-Behavioral Therapy

Hypnotherapy

EXPERIMENTAL

Behavioral: Hypnotherapy

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)

Cognitive-Behavioral Therapy

Hypnotherapy BEHAVIORAL

hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)

Also known as: hypnosis

Hypnotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• smoking at least 10 cigarettes per day
• smoking at least for the past two years
• fluency in German language
• willing and able to give written informed consent

You may not qualify if:

• women: planned or current pregnancy or breast-feeding
• participation in a smoking cessation program within the last 6 months
• severe mental illness

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

University Hospital of Tuebingen Smoking Cessation Research Group

Tübingen, 72070, Germany

Location

Related Publications (1)

• Batra A, Eck S, Riegel B, Friedrich S, Fuhr K, Torchalla I, Tonnies S. Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial. Front Psychol. 2024 Feb 27;15:1330362. doi: 10.3389/fpsyg.2024.1330362. eCollection 2024.

  PMID: 38476396 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Color Vision Defects

Interventions

Cognitive Behavioral Therapy; Hypnosis

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Anil Batra, Prof.

  University Hospital Tuebingen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 25, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

DE (1)